Drug Safety

, Volume 32, Issue 1, pp 1–18 | Cite as

Vision Disorders and Phosphodiesterase Type 5 Inhibitors

A Review of the Evidence to Date
  • Alan M. LatiesEmail author
Review Article


Phosphodiesterase type 5 (PDE-5) inhibitors (sildenafil, vardenafil and tadalafil) have been in widespread use for the safe and effective treatment of erectile dysfunction (ED) for nearly a decade. During that time, a relatively small number of patients have experienced adverse visual events, including nonarteritic anterior ischaemic optic neuropathy (NAION). In this article, post-marketing reports of adverse visual events along with other relevant literature on ocular safety related to PDE-5 inhibitor use are reviewed. Although a relatively small number of cases have been reported with a possible temporal association with PDE-5 inhibitor use, it has not been possible to conclude whether these events are coincidental or whether they are associated with effects of PDE-5 inhibitors on ocular circulation or on other structures of the eye. A careful review of pooled data from clinical trials for all three PDE-5 inhibitors, which contain well documented information about the dose and duration of exposure to the drug for a large number of patients, yields no evidence for an increased risk of NAION or other adverse ocular events associated with PDE-5 inhibitor use. However, the inherent limitations in interpreting results from clinical trials and potentially incomplete information from post-marketing surveillance preclude a definitive declaration that ocular safety will not be a concern for some patients with ED and comorbid disease states. Despite the absence of a proven link between PDE-5 use and serious ocular disorders, physicians should continue to advise patients to stop use of a PDE-5 inhibitor and seek immediate medical attention in the event of a sudden loss of vision as a safety measure.


Erectile Dysfunction Retinal Nerve Fibre Layer Obstructive Sleep Apnoea Tadalafil Retinal Nerve Fibre Layer Thickness 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



Editorial support was provided by Donald G. Buerk, PhD, of Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.

Alan Laties received grant support from, was a study investigator for, and is a consultant to Pfizer Inc.


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Copyright information

© Adis Data Information BV 2008

Authors and Affiliations

  1. 1.Department of OphthalmologyScheie Eye Institute, University of Pennsylvania School of MedicinePhiladelphiaUSA

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